The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 2 January 2026, authorised zapomeran (Kostaive) for the immunisation of adults aged 18 and over. The vaccine is a single 0.5 mL booster administered intramuscularly in the upper arm. It uses self‑amplifying messenger RNA to instruct cells to temporarily produce the SARS‑CoV‑2 spike protein. Very common reactions include injection‑site pain or tenderness, tiredness, chills, fever, muscle or joint pain, headache and dizziness; these are typically mild and resolve within a few days. The MHRA will publish the Summary of Product Characteristics and Patient Information Leaflet within seven days and will maintain routine post‑authorisation safety monitoring via the Yellow Card scheme.
The decision was made under the International Recognition Procedure, with the European Medicines Agency acting as the reference regulator for this application (EMA file EMEA/H/C/006207/0000).
Under MHRA guidance, IRP offers two timetables: Recognition A (60 days) and Recognition B (110 days) from validation, with the option to revert to B if major objections arise.
MHRA positions IRP as part of its post‑EU regulatory model, allowing the agency to draw on assessments from trusted partners while retaining UK decision‑making. Partners include the EMA and regulators in Australia, Canada, Japan, Singapore, Switzerland and the United States; the published time horizons are 60–110 days.
Suspected side effects should be reported by patients and healthcare professionals through the MHRA Yellow Card website or mobile app. These reports support detection of rare or unexpected events and complement routine surveillance.
MHRA’s Interim Executive Director for Healthcare Quality and Access, Julian Beach, said the authorisation provides an additional adult option against COVID‑19 and confirmed that safety will be closely monitored as uptake grows.
For programme leads and vaccinators: zapomeran is indicated as an adult booster. Consult the SmPC and Patient Information Leaflet on the MHRA Products website, once published, for dosing, contraindications and other instructions.